NCT01413386终止不适用
A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.
Jong Taek, Lee5 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- Accumulative Patency Rate
研究概览
简要总结
Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.
详细描述
Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who submitted a written informed consent for the this trial, and 18 ~ 90 years old
- •Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
- •Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
- •Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
- •Patient who have life expectancy at least longer than 3 months (Karnofsky score >60%)
排除标准
- •Patient who previously had surgical biliary drainage
- •Patient who carrying bleeding disorder
- •Patient who have combined Hilar and/or intra-hepatic duct cancer
- •Patient who is improper to endoscopic treatment
结局指标
主要结局
Accumulative Patency Rate
时间窗: 6 months
次要结局
- Possibility of Other Treatment after Obstruction(6 months)
- Accumulative Survival Rate(6 months)
- Stent migration rate(6 months)
研究者
Jong Taek, Lee
Taewoong Medical Co., Ltd.
Taewoong Medical Co., Ltd.
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary StentBiliary StrictureMalignant NeoplasmsNCT01512563Taewoong Medical Co., Ltd.106
已完成
不适用
Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary DecompressionObstructive JaundicePancreatic CancerNCT01675908AdventHealth46
已完成
3 期
A phase III study of covered versus bare metallic stents for the treatment of malignant bile duct obstruction (JIVROSG-0207)Malignant common bile duct obstructionJPRN-C000000043Japan Interventional Radiology in Oncology Study Group (JIVROSG)60
已完成
不适用
Efficacy of metallic stent for benign biliary stricture.Benign biliary strictureJPRN-UMIN000019271Yokohama city university hospital, Department of Gastroenterology and Hepatology.30
已完成
不适用
Covered Versus Uncovered Biliary Stents for Biliary MalignanciesBiliary Tract CancerNCT02102984Nuovo Ospedale Civile S.Agostino Estense140
